Global R&D Compliance & Audit Strategy Lead

BeOne Medicines Ltd.; California; On-site; USD 150,000 - 190,000; Full time

Job summary

BeOne Medicines seeks a Senior Director, Global R&D Audits & Inspections Readiness to lead regulatory compliance across R&D IT and development. You will embed Validation-by-Design into Agile workflows and CI/CD pipelines, and orchestrate inspections.

Translate global GxP and data privacy requirements into actionable engineering guardrails, guiding teams through CSV and CSA methodologies, and fronting regulatory inspections.

Qualifications

• Must have deep knowledge of GxP regulatory requirements.
• Experience with Computerized Systems Validation (CSV).
• Experience with Computer Software Assurance (CSA) methodologies.
• Familiarity with FDA 21 CFR Part 11 and EMA Annex 11.

Responsibilities

• Lead in-house product validation and lifecycle integration across R&D IT.
• Oversee audits, inspections, and readiness activities with cross-functional teams.
• Embed compliance into Agile/Scrum and CI/CD processes.
• Translate regulatory requirements into engineering guardrails and SDLC checks.

Skills

GxP compliance

CSV

CSA

FDA Part 11

Agile/Scrum

CI/CD pipelines

Regulatory liaison

Job description

BeOne Medicines seeks a Senior Director, Global R&D Audits & Inspections Readiness to lead regulatory compliance across R&D IT and development. You will embed Validation-by-Design into Agile workflows and CI/CD pipelines, and orchestrate inspections.

Translate global GxP and data privacy requirements into actionable engineering guardrails, guiding teams through CSV and CSA methodologies, and fronting regulatory inspections.